A unique long acting anticoagulant

In 2004, ThromboGenics entered into a strategic collaborative research and licensing agreement with BioInvent to co-develop ThromboGenics’ novel antibody-based drugs. Currently, the partners are jointly developing TB-402 (anti-Factor VIII) and TB- 403 (anti-PlGF).

TB-402 is a novel human antibody binding to Factor VIII, an essential blood clotting factor. TB-402 is being developed as an anti-coagulant for the treatment and prevention of venous thromboembolic disorders such as deep vein thrombosis and atrial fibrillation.

In 2007, ThromboGenics has successfully completed a Phase I clinical trial with TB-402. The study was a randomized, placebo-controlled, dose escalation trial in healthy male volunteers, and the objective was to investigate safety, tolerability and pharmacokinetic properties of the drug candidate. 56 volunteers were enrolled into the trial, both young and old. Preliminary results of the trial showed that TB-402 met both the primary (safety and tolerability) and secondary (pharmacokinetic and pharmacodynamic) endpoints. The drug was well tolerated and the study showed that TB-402’s prolonged half-life may allow for single-dose treatment in orthopedic surgery patients and/or once a month administration for long-term stroke prevention in atrial fibrillation as opposed to current daily treatment. Importantly, the findings confirm that TB-402 achieves only partial inhibition of Factor VIII activity without the undesired effect of increased bleeding tendency in the case of total Factor VIII inactivation nor the need for regular monitoring of blood coagulation.

As part of the development program, drug interaction studies are being performed in parallel with the preparation for Phase II, which is expected to start in Q4 2008. The initial Phase II trial will be a dose-ranging clinical trial evaluating safety and efficacy (ability to prevent deep vein thrombosis) in an orthopedic surgery setting.

The results of the Phase I clinical trial were presented at the ASH meeting on Dec 10, 2007. ASH presentation »